Guselkumab for Psoriatic Arthritis

(SOLSTICE Trial)

Not currently recruiting at 277 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: JAK inhibitors, Immunosuppressants

Disqualifiers: Rheumatoid arthritis, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of guselkumab for individuals with active psoriatic arthritis (PsA) who haven't found success with other treatments. Guselkumab may help reduce joint swelling and pain caused by PsA. Participants will receive either guselkumab, a placebo (a harmless substance resembling the treatment), or a combination of both. The trial seeks individuals who have had PsA for at least six months, with at least three swollen and tender joints, and who have tried other treatments without success. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic immunosuppressants (medications that lower the immune system's activity) at least 4 weeks before starting the study. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that guselkumab is likely to be safe for humans?

Research shows that guselkumab is generally safe for people with psoriatic arthritis. Studies have found no new safety issues for up to one year, based on trials where patients received guselkumab every four or eight weeks. Guselkumab has a proven safety record with two years of data in psoriatic arthritis and five years in plaque psoriasis, indicating extensive study across different conditions. Overall, the treatment is considered safe, with no major unexpected side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriatic arthritis?

Guselkumab is unique for psoriatic arthritis treatment because it specifically targets interleukin-23 (IL-23), a protein involved in inflammatory processes. Unlike other treatments, such as TNF inhibitors or non-biologic DMARDs, guselkumab offers a novel mechanism of action that directly interferes with IL-23, potentially providing a more targeted approach to reducing inflammation and symptoms. Researchers are excited about guselkumab because its specificity might lead to better efficacy and safety profiles compared to existing options, improving patient outcomes.

What evidence suggests that guselkumab might be an effective treatment for psoriatic arthritis?

Research has shown that guselkumab effectively treats psoriatic arthritis (PsA). It reduces symptoms of active PsA and prevents joint damage. In studies, most patients experienced improved joint health, with 70.3% showing a significant decrease in joint inflammation on MRI scans. Additionally, guselkumab improved disease activity over a year, helping many patients manage their condition better. This treatment targets a specific protein (IL-23) that plays a key role in PsA-related inflammation. Participants in this trial may receive guselkumab alone, guselkumab with placebo, or placebo followed by guselkumab, as part of the different treatment groups under study. ^{2 6 7 8 9}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for people with active psoriatic arthritis who haven't responded well to or can't tolerate a previous anti-TNF alpha treatment. They should have had PsA for at least 6 months, meet specific criteria, and show certain symptoms like swollen/tender joints and elevated CRP levels.

Inclusion Criteria

I have active psoriasis with a plaque of 2cm or larger, nail changes, or a history of plaque psoriasis.

I have active psoriasis with a plaque of 2cm or larger, nail changes, or a history of plaque psoriasis.

I have been diagnosed with psoriatic arthritis for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 weeks

Blinded Treatment

Participants receive either guselkumab or placebo subcutaneously during a placebo-controlled period

24 weeks

Regular visits for treatment and monitoring

Active-controlled Treatment

Participants receive guselkumab subcutaneously during an active-controlled treatment phase

76 weeks

Regular visits for treatment and monitoring

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Guselkumab

Trial Overview The study tests the effectiveness of guselkumab in reducing symptoms of PsA compared to a placebo in those who didn’t respond to prior TNF blockers. Participants will be randomly assigned to receive either guselkumab or a placebo.

How Is the Trial Designed?

Group I: Group 3: Placebo Followed by Guselkumab Experimental Treatment 2 Interventions

Participants will receive placebo SC and will cross over to receive guselkumab SC.

Group II: Group 2: Guselkumab Experimental Treatment 1 Intervention

Participants will receive guselkumab SC.

Group III: Group 1: Guselkumab and Placebo Experimental Treatment 2 Interventions

Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.

Guselkumab is already approved in United States, European Union for the following indications:

Approved in United States as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Approved in European Union as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Guselkumab is an approved treatment for moderate-to-severe plaque psoriasis, specifically designed to inhibit interleukin 23 (IL-23), which plays a key role in the inflammatory process of the disease.

By blocking IL-23 from binding to its receptor, guselkumab disrupts the IL-17 pathway, which is crucial for the activation of type 17 helper T cells, thereby reducing inflammation and symptoms in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: First Global Approval. Markham, A.[2019]

In a phase 2a trial involving 149 patients with active psoriatic arthritis, guselkumab significantly improved symptoms, with 58% of patients achieving at least a 20% improvement in their condition compared to only 35% in the placebo group, demonstrating its efficacy as a treatment.

Guselkumab was well tolerated over 44 weeks, with a similar rate of adverse events (36% in the treatment group vs. 33% in the placebo group), indicating a favorable safety profile for this novel therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Deodhar, A., Gottlieb, AB., Boehncke, WH., et al.[2020]

Guselkumab (GUS) demonstrated a favorable safety profile in patients with psoriatic arthritis (PsA), showing low adverse event (AE) rates for both TNFi-naïve (139.7/100 patient-years) and TNFi-experienced patients (174.0/100 patient-years) over a period of up to 2 years.

The safety outcomes, including rates of serious AEs and treatment discontinuation, were consistent between GUS-treated patients and those receiving placebo, indicating that GUS is a safe treatment option for PsA regardless of prior TNFi use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. Rahman, P., Boehncke, WH., Mease, PJ., et al.[2023]

In the phase 3b COSMOS trial, guselkumab, an IL-23 inhibitor, was effective in reducing disease activity in adults with active psoriatic arthritis who had inadequate responses to tumor necrosis factor inhibitors, showing significant decreases in inflammatory markers like CRP and IL-17 levels by Week 24.

Participants treated with guselkumab exhibited a notable improvement in clinical response, with higher baseline levels of IL-22 and IFNɣ associated with better outcomes, indicating a potential biomarker for treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study. Schett, G., Chen, W., Gao, S., et al.[2023]

In a phase II trial involving 149 patients with active psoriatic arthritis, guselkumab significantly improved symptoms of enthesitis and dactylitis compared to placebo, with these improvements sustained through week 56.

Patients who switched from placebo to guselkumab treatment experienced similar benefits in enthesitis and dactylitis as those who received guselkumab from the start, indicating its effectiveness regardless of when treatment began.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study. Mease, PJ., Gladman, DD., Deodhar, A., et al.[2021]

In the DISCOVER-2 trial, guselkumab was tested in biologic-naive patients with active psoriatic arthritis, demonstrating significant efficacy in reducing disease activity compared to placebo.

The study's double-blind, randomized, placebo-controlled design ensures robust results, highlighting guselkumab as a promising treatment option for patients who have not previously received biologic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis. Schattner, A.[2020]

In a study of 285 adults with psoriatic arthritis who had previously not responded to tumor necrosis factor inhibitors, guselkumab significantly improved joint symptoms, with 44.4% of patients achieving a 20% improvement in their condition (ACR20) compared to 19.8% in the placebo group at week 24.

Guselkumab demonstrated a favorable safety profile, with low rates of serious adverse events (3.7%) and no deaths or opportunistic infections reported, indicating it is a safe treatment option for patients with TNFi-resistant psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Coates, LC., Gossec, L., Theander, E., et al.[2022]

Guselkumab is a human monoclonal antibody that selectively blocks IL-23, which is important in the development of psoriasis and psoriatic arthritis, and it was approved for treating active psoriatic arthritis based on data from two phase-3 studies (DISCOVER-1 and -2).

This treatment represents a new therapeutic option for patients with active psoriatic arthritis, demonstrating both efficacy and safety, and it is the first selective IL-23 inhibitor to receive FDA approval for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis in Adults. Boehncke, WH., Brembilla, NC., Nissen, MJ.[2021]

Guselkumab is an effective treatment for moderate to severe plaque psoriasis, showing superior results compared to placebo and adalimumab in the VOYAGE trials, with benefits maintained for up to 2 years.

Patients who previously did not respond well to ustekinumab showed significantly better outcomes when switched to guselkumab, indicating its efficacy in treatment-resistant cases, while also improving overall quality of life and being well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. Al-Salama, ZT., Scott, LJ.[2019]

Citations

1. jnj.com jnj.com/media-center/press-releases/new-data-show-tremfya-guselkumab-is-the-only-il-23-inhibitor-proven-to-significantly-inhibit-progression-of-joint-structural-damage-in-active-psoriatic-arthritis

New data show TREMFYA® (guselkumab) is the only IL-23 ... TREMFYA (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38598432/

Short-term effectiveness of guselkumab in psoriatic arthritis ... A reduction of 0.80 or larger in the sacroiliac joint lesion score was observed in the majority of patients (70.3%) based on MRI improvements, ...

3. jnjmedicalconnect.com jnjmedicalconnect.com/products/tremfya/medical-content/tremfya-efficacy-outcomes-by-weight-in-adult-patients-with-plaque-psoriasis-or-psoriatic-arthritis

TREMFYA - Efficacy Outcomes by Weight in Adult Patients ... Super response (SR) status was defined as patients who received TREMFYA and achieved PASI 100 (absolute PASI = 0) response at weeks 20 and 28.

4. rheumatologyadvisor.com rheumatologyadvisor.com/news/guselkumab-improves-psa-disease-activity/

Guselkumab Improves Disease Activity and Retention in PsA Treatment with guselkumab led to improvements in disease activity over 1 year among patients with PsA and showed a high retention rate.

5. tremfyahcp.com tremfyahcp.com/plaque-psoriasis/efficacy-in-joints/

Efficacy in Active PsA: Moderate to Severe Plaque PsO Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37906417/

Long-Term Safety of Guselkumab in Patients with Psoriatic ... Guselkumab was well tolerated and efficacious across individual pivotal clinical studies in adults with moderate-to-severe psoriasis and/or active psoriatic ...

7. tremfyahcp.com tremfyahcp.com/psoriatic-arthritis/

Active Psoriatic Arthritis (PsA) - TREMFYA ® (guselkumab) TREMFYA ® has a proven safety profile across psoriatic disease with 5 years of data in moderate to severe plaque psoriasis (PsO) and 2 years of data in

8. jrheum.org jrheum.org/content/48/12/1815

Pooled Safety Results Through 1 Year of 2 Phase III Trials ... Guselkumab 100 mg Q4W and Q8W were well tolerated in patients with PsA, with no new safety concerns through 1Y of the phase III DISCOVER trials.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02319759

NCT02319759 | Efficacy and Safety Study of Guselkumab ... The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA). Detailed ...